Unit testing and IEC 62304
In software development, unit testing refers to the testing of software units. However, there is no common understanding of This article provides clarity.
Details21 CFR part 11: An over-interpreted law?
In 21 CFR part 11, the FDA establishes its requirements for electronic records and signatures, which also apply to medical device manufacturers. A lot of companies print everything out on paper and then sign it by hand to circumvent the requirements of part 11. Is this really necessary?
DetailsSystems and procedure packs
The European legislation defines systems and procedure packs and distinguishes between different configurations. The regulatory requirements placed on the manufacturer are heavily dependent on these configurations. This article will explain to you what legislators understand by systems and procedure packs, what the most important legal requirements are for manufacturers, and what common mistakes you should avoid.
DetailsElectronic and digital signatures
Electronic and digital signatures should be considered on an equal level to handwritten signatures (“wet ink”). The requirements that need to be fulfilled depend on the extent of the binding force that is to be achieved and so depend on the document that is to be signed. This article explains
DetailsSampling kits from a regulatory perspective
The term “sampling kit” is not defined by the IVDR or any other regulation. Nevertheless, there are (indirect) regulatory requirements that IVD manufacturers and medical laboratories must be aware of and consider. The requirements depend on the particular constellation. This article presents five constellations. It provides clarity and helps to avoid regulatory hassles and minimize…
DetailsPICO scheme: The method for systematic and structured literature research
“Follow the PICO scheme.” This is the recommendation of many auditors and reviewers, as well as some regulatory documents (such as MDCG guidelines and MEDDEV 2.7/1 rev.4), regarding precise medical literature searches. Read in this article,
DetailsWhy you should consider clinical studies in Australia
Conducting clinical studies in Australia is not on the radar of many medical device manufacturers. However, good reasons exist to consider this continent for clinical studies or investigations. Yet manufacturers should also be aware of Australia’s regulatory requirements and specific disadvantages.
CAPA: Corrective and Preventive Actions
What MDR and IVDR confuse and why you should not talk about CAPA. The FDA (in 21 CFR part 820 – QSR) and ISO 13485 differentiate between Unfortunately, the MDR and IVDR do not clearly differentiate between these concepts. Some manufacturers also believe they can combine corrective and preventive actions into one single CAPA process. But…
DetailsUnderstanding and avoiding deviations and nonconformities
Deviations, nonconformities, errors, findings, observations, and other terms are often used mistakenly synonymously. Even standards explicitly contradict each other when defining individual terms. This article clarifies,
DetailsThe EU regulates medical laboratories – Are Laboratory Developed Tests still allowed?
This article will help you ensure that you will still be able to offer in-house IVD (also called Laboratory Developed Tests, LDTs) under the IVDR and will explain the three options open to you avoiding legal disputes. In-house IVD are a type of in vitro diagnostic test. But do regulatory requirements such as the IVDR also…
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